MAUDE Adverse Event Report: ADIN DENTAL IMPLANTS LTD. ADIN DENTAL IMPLANTS; ISPX0849

Catalog Number	ISPX0849
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Inadequate Osseointegration (2646)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bone loss and infection 6 month after implantation.

• Brand Name: ADIN DENTAL IMPLANTS
• Common Device Name: ISPX0849
• Manufacturer (Section D): ADIN DENTAL IMPLANTS LTD.; industrial zone alon tavor; pob 1128; afula, isr, 18111 01; IS 1811101
• MDR Report Key: 22124075
• Report Number: 3013143972-2025-00309
• Device Sequence Number: 15627628
• Product Code: DZE
• UDI-Device Identifier: 07290105152169
• UDI-Public: 7290105152169
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/02/2025
• Report Date (Section F): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ISPX0849
• Device Lot Number: 7793801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/02/2025